Assessment of Bupropion on Cognitive Function and Behaviour in Healthy Volunteers
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Purpose
To evaluate the effects of a 14-day repeated dose of 150 mg bupropion (therapeutic dose) on cognitive and executive functions, behaviour and subjective feelings, after sleep deprivation in 12 healthy male subjects.
| Condition | Intervention |
|---|---|
|
Healthy |
Drug: Bupropion |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Assessment of Bupropion on Cognitive Function and Behaviour in Healthy Volunteers |
- Cognitive and executive functions after the first dose and the 14-day treatment.Subjective feelings after the first dose and the 14-day treatment : ARCI, Norris and POMS scales.
- Sleep questionnaire after the 14-day treatment. Energy intake after the 14-day treatment. Blood pressure after one dose and the 14-day treatment
| Estimated Enrollment: | 12 |
| Study Start Date: | November 2004 |
| Study Completion Date: | February 2006 |
The aim of this controlled double-blind randomized 3-session cross-over designed study is to evaluate the effects of a single dose of 150 mg and a 14-day repeated dose of 300 mg bupropion (therapeutic dose) on cognitive and executive functions, behaviour and subjective feelings, and some physical parameters after sleep deprivation in 12 trained healthy volunteers (18-35 years old).
Cognitive and executive functions were assessed by reaction times, critical flicker fusion test, Stroop test, digit symbol substitution test, span test and short term recal of pictures, tapping and tracking tests.
Behaviour and subjective effects explored were :
- feelings frequently experienced with psychotropic drugs assessed by ARCI,
- some mood states as tension, depression, anger, vigor, fatigue and confusion assessed by both POMS and Norris visual analogic scales,
- sleep assessed by LSEQ,
- feeding behaviour assessed by food intake during a meal test and self-ratings of appetite and satiety,
Physical parameters were :
- rest and orthostatic blood pressure and heart rate,
- body temperature and weight.
Bupropion was tested versus both placebo and 20 mg methylphenidate as positive control. Each subject received the 3 treatments, sequently randomized, with a 17-day wash-out period between sessions. Each session was organized as follow :
- 2 20-hour hospitalisations consisting in adverse effects review, physical examination, test training, sleep deprivation, drug compliance evaluation, drug dosing and dispensation, and assessments described above,
- 2 visits consisting in adverse effects review, drug compliance evaluation and drug dispensation.
The total duration of participation for the subjects was 106 days.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- BMI between 20.0 and 25.00
- no smoker
Exclusion Criteria:
-
Contacts and Locations| France | |
| Centre d'Investigation Clinique | |
| Montpellier, France, 34295 | |
| Principal Investigator: | Pierre PETIT, MD-PhD | Centre d'Investigation Clinique |
More Information
No publications provided by University Hospital, Montpellier
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00285155 History of Changes |
| Other Study ID Numbers: | UF7759 |
| Study First Received: | January 31, 2006 |
| Last Updated: | August 8, 2007 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Montpellier:
|
bupropion repeated dose healthy volunteers cognitive function |
behaviour tolerance Persons |
Additional relevant MeSH terms:
|
Bupropion Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013